Igor Stefanov
CEO @ SRG CRO & A Kingsman @ ACROSS Global™
I’m pleased to introduce to you the European edition of our Orange Paper.
Accrording to CT.GOV data, 6,396 new clinical trials of all types were started suring Q3 2018 worldwide. This comprises local and bioequivalence studies. There were 2,076 studies approved in USA and 1,615 trials were approved in 17 leading European countries. This translates to worldwide overall year on year growth rates of 19% worldwide, 8% in USA and a 23% decline in 17 leading European countries by number of studies (we set a threshold of as minimum 20 Clinical trials conducted in Q3 2018 as inclusion criteria for European countries).
Phase III Lion’s Share
Interventional clinical trials are the dominant type of research with 82% market share worldwide, 90% in USA and 82% in Europe. The most prevalent phase of clinical trials conducted worldwide by number of studies was Phase II. The dominant phase of clinical trials conducted across European sites by number of studies and patients was Phase III.
More Patients in Europe
The worldwide population of patients enrolled in clinical trials of all types in Q3 2018 reached 1.2 million people; approximately one half of them are enrolled in in interventional trials with identified study Phases I – IV. The majority of patients are enrolled in Phase III trials, and the largest growth in the global patient population was seen in Europe. However, the share of patients participating in clinical trials remains extremely low in comparison with the overall size of population – approximately 0,02% worldwide, 0,05% in USA, 0,07% in the 17 leading European countries. The most prevalent therapeutic areas of clinical trials are Oncology and Cardiology.
Top Ten Sponsors
Top ten sponsors by the number of new studies were: Hoffmann-La Roche, AbbVie, Bristol-Myers Squibb, Bayer, AstraZeneca, Merck, Eli Lilly, Janssen, Novartis and Sanofi.
In Europe the top ten sponsors combined account for 15% of total number of studies conducted in Europe in this quarter. In comparison, in the USA the top ten sponsors combined account for only 7% of total number of studies.
EMA Approvals
During Q3 2018 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) evaluated 21 new drugs. One drug was withdrawn, 20 drugs received positive opinions and were approved for marketing.
FDA Approvals
In the same quarter, the Center for Drug Evaluation and Research (CDER) of the FDA approved 13 new drugs; four of them were new molecular entities (NME); various improvements in existing pharmaceutical products.
FDA Inspections
According to the FDA data, 2 FDA inspections were conducted in investigative sites located in Czech Republic during Q3 of 2018.
Tech Trends in Clinica Trials
Three top tech trends in the Pharmaceuticals industry in Q3 2018 were:
Patient Centricity. Improving quality of Patient Relationship with patient-faced services like Medication Adherence apps, Telemedicine services and In-Home Diagnostic devices;
Risk-based Solutions. Improving quality, speed and cost-efficiency in Clinical trials with Risk Management solutions, Study Data Analysis tools and Study Compliance systems;
Artificial Intelligence. Improving speed and cost-efficiency in Clinical Practice of Healthcare Providers with AI-powered automated Diagnostic tools and voice-powered Physician’s Assistant tools.
You can download a free 20-page PDF version here. No registration required so far.
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Igor Stefanov is CEO of Synergy Research Group, the World’s First Agile Risk-Based CRO, totally devoted to the Risk Based Thinking in Drug Development.